Class 2 Device Recall ACCUCHEK Tender II Infusion Set

• Date Initiated by Firm: November 20, 2014
• Date Posted: December 30, 2014
• Recall Status: Terminated on January 10, 2018
• Recall Number: Z-0893-2015
• Recall Event ID: 69821
• 510(K)Number: K972135
• Product Classification: Set, administration, intravascular - Product Code FPA
• Product: ACCU-CHEK Tender II 17/80 10 + 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections through the injection port. The indwelling catheter can also be securely attached to the infusion catheter by means of a proprietary click-lock connector for the infusion of drugs subcutaneously. The infusion set can be detached from the indwelling catheter, and the catheter capped to allow freedom from the infusion set and pump for showers, athletics or other activities.
• Code Information: Catalog: 04541529001 and lots: 5044354, 5051306, 5058507, and 5062209.
• Recalling Firm/ Manufacturer: Roche Diagnostics Operations, Inc.; 9115 Hague Rd; Indianapolis IN 46256-1025
• For Additional Information Contact: Anne Gill; 317-521-4312
• Manufacturer Reason for Recall: Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets, about potential for the the tubing of the infusion set to become detached at the connect/disconnect location on the ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets. If tubing detachment occurs, insulin delivery is interrupted and the pump will not alarm to notify
• FDA Determined Cause: Device Design
• Action: Roche sent the "Urgent Medical Device Corrections" letter dated 12/1/2014 via UPS Ground (receipt required) to the Patients, and Distributors who received the affected device. The letter included a description of the reason for recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. No product returns were expected. For questions, contact the ACCU-CHEK Pump Support at 1-800-688-4578.
• Quantity in Commerce: Total of 13,041 boxes
• Distribution: US Nationwide Distribution
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FPA